EVIS SIGMOIDOVIDEOSCOPE

GUDID 04953170339912

"PCF-S FLEXIBLE SIGMOIDOSCOPE"

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video sigmoidoscope

• Primary Device ID: 04953170339912
• NIH Device Record Key: a3fc79eb-1bec-4878-b374-bb24e2056f87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS SIGMOIDOVIDEOSCOPE
• Version Model Number: OLYMPUS PCF TYPE S
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170339912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954451

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

[04953170339912]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17
• 04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip: 2024-09-17
• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
• 14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 14953170409971 - Single Use Aspiration Needle NA-U401SX: 2024-07-11